—#154482

Product

Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K101347
Affected lot / code info: Model Number: 10684336, 10684337 Serial Number: 12811002 12811003 12811017

Why it was recalled

Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

Siemens mailed an Customer Safety Advisory Notice on October 17, 2016, to all affected customers to inform them of the corrective action they plan to take to correct the issue. The notice also informed users of the possible risks to patients and how the corrective action will be implemented. For further questions, please call (610) 448-6461.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Distribution to: DC and MD.

Timeline

Recall initiated: 2016-10-17
Terminated: 2017-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154482. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.